Screen Printed Electrodes For An Electrocardiogram Article

ABSTRACT

A wearable diagnostic electrocardiogram (ECG) garment is disclosed herein. The wearable diagnostic ECG garment comprises a garment body, screen-printed electrodes positioned on the body, and screen-printed wires positioned in the garment body, each of the screen-printed wires connected from a central connector module to a screen-printed electrode.

CROSS REFERENCES TO RELATED APPLICATIONS

The Present Application claims priority to U.S. Provisional PatentApplication No. 63/147,191, filed on Feb. 8, 2021, and is acontinuation-in-part application of U.S. patent application Ser. No.16/812,330, filed on Mar. 8, 2020, which claims priority to U.S.Provisional Patent Application No. 62/819,025 filed on Mar. 15, 2019,now expired, and U.S. Provisional Patent Application No. 62/825,018filed on Mar. 27, 2019, now expired, and U.S. patent application Ser.No. 16/812,330 is a continuation-in-part application of U.S. patentapplication Ser. No. 15/990,651, filed on May 27, 2018, which is acontinuation application of U.S. patent application Ser. No. 15/853,578,filed on Dec. 22, 2017, now U.S. Pat. No. 9,986,929, issued on Jun. 5,2018, which claims priority to U.S. Provisional Patent Application No.62/465,752, filed on Mar. 1, 2017, now expired, and also claims priorityto 62/530,144, filed on Jul. 8, 2017, now expired, each of which ishereby incorporated by reference in its entirety, and the PresentApplication is a continuation-in-part application of U.S. patentapplication Ser. No. 17/106,125, filed on Nov. 29, 2020, which is adivisional of U.S. patent application Ser. No. 15/904,411, filed on Feb.25, 2018, now U.S. Pat. No. 10,893,818, issued on Jan. 19, 2021, whichis a continuation-in-part application of U.S. patent application Ser.No. 15/853,578, filed on Dec. 22, 2017, each of which is herebyincorporated by reference in its entirety.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable

BACKGROUND OF THE INVENTION Field of the Invention

The present invention generally relates to ECG devices.

Description of the Related Art

The electrocardiogram (ECG) is an essential test that provides medicalprofessionals with essential information in the management of patientswith a variety of conditions. It is not only of significant importancein the evaluation and management of patients with chest pain, but alsoin patients with shortness of breath, syncope, dizziness, seizures,altered mental status, stroke, psychiatric conditions, overdose,palpitations and many other conditions. It is a bulky system with amultitude of wires and connections.

The ECG provides critical data to the health care provider in managingpatients with multiple medical issues. The time to obtain this data iscritical and often delayed by the current technology. Minutes can becomecritical in the patient with an acute myocardial infarction (heartattack).

Historically, there is training in the interpretation of ECG data, aswell as placement of electrodes on the chest of each patient inanatomically specific positions.

Current ECG placement is done by technicians and providers of varyingmedical background, including paramedics, health care technicians,nursing assistants, nurses, and doctors. The current technology isbulky, with many wires and cables. The placement of the electrodes inthe acquisition of an ECG is specific and requires special training. ECGacquisition is often limited and/or delayed by multiple factors such asbody sweat, ability to transport the ECG device into confined areas,performance of concomitant medical procedures such as cardiopulmonaryresuscitation (CPR). Because of many limitations, medical providers mustmake rapid decisions and potentially delay medical care while ECGtesting is done. As emergency medicine providers, the inventors haveidentified a need for more rapid placement of the ECG electrodes, a moreportable and manageable system that will not compromise medical care,and the need to eliminate electrode placement errors.

Sujdak, U.S. Pat. No. 6,847,836 for an Emergency ECG Electrode Chest Paddiscloses a chest pad adapted for use in an emergency room.

Dominguez, U.S. Pat. No. 6,560,473 for a Disposable ECG Chest ElectrodeTemplate With Built-In Defibrillation Electrodes discloses a templatethat carries ten electrodes.

The acquisition of a 12-lead ECG requires accurate placement ofelectrodes and avoidance of lead transposition. This has been achallenge for many healthcare workers and staff that place ECGelectrodes. For lay persons outside of the healthcare setting thisrequires expertise not typically expected of the general population.Heart disease is still the number one cause of death in the UnitedStates. With an ever-increasing aged population, the timely diagnosis ofheart disease and risk stratification is key to improved morbidity andmortality. The 12-lead ECG is central to this diagnosis and management.Technology is enabling extension of the health care continuum to expandinto the home and away from a hospital or clinical setting. With apopulation of educated patients that value time and utility of theirhealth care data, the ability to transmit and interpret reliable ECGdata outside of the standard health care setting allows patients to takeeven more ownership of their health.

BRIEF SUMMARY OF THE INVENTION

The motivation for the present invention is to make garments capable ofmaking diagnostic electrocardiogram access to a population both withinand outside traditional health care settings, thus enabling a diagnosticquality ECG to be obtained that conforms to American Heart Associationguidelines on diagnostic resting ECGs and also capable of obtainingcontinuous diagnostic ECG monitoring and acquisition during times ofexercise and exertion. The device allows for electrode placement in keypositions that conform to proximal limb positions and precordial chestpositions that allow for a diagnostic-quality ECG to be obtained.Further, the garment allows for this to be applied by both lay personsand medically trained staff

The present invention incorporates screen-printed ECG electrodes andconducting circuits into a wearable, stretchable, and elastic garmentwith integrated electrical conducting materials that transferphysiologic electrical signals to a central processing unit for ECGacquisition and interpretation. The garment is available in multiplesizes to accommodate different body types. The garment is reusable,washable, and durable. The device can be used repeatedly by the sameuser or it can be multi-used between persons with similar sizingconstraints.

The acquisition of a 12-lead ECG requires accurate placement ofelectrodes and avoidance of lead transposition. This has been achallenge for many healthcare workers and staff that place ECGelectrodes. For lay persons outside of the healthcare setting thisrequires expertise not typically expected of the general population.Heart disease is still the number one cause of death in the UnitedStates. With an ever-increasing aging population, the timely diagnosisof heart disease and risk stratification is key to improved morbidityand mortality. The 12-lead ECG is central to this diagnosis andmanagement. Technology is enabling extension of the health carecontinuum to expand into the home and away from a hospital or clinicalsetting. With a population of educated patients that value time andutility of their health care data, the ability to transmit and interpretreliable ECG data outside of the standard health care setting allowspatients to take even more ownership of their health. The use ofECG-enabled garments also allows this data to be obtained sooner andmore reliably among patients presenting to any triage situation, whetherthat is in the pre-hospital setting or the setting of a crowdedemergency room. Smart-garments with multi-sensor monitoring of key vitalsigns will help to address the dangers in recognizing which triagedpatients are experiencing changes in vital signs that may signify moreabrupt needs for care and resource allocation.

A multitude of electrodes and conducting materials is incorporated intoa stretchable, elastic garment with indexed positions that meet AmericanHeart Association diagnostic criteria for ECG analysis, and connected toa central unit that transmits acquired electrical signals to an ECGalgorithm monitor (with or without signal amplification) via wireless orwired technology to a cloud based data evaluation system and physicianconfirmed interpretation. By incorporation into a simple garment systemit is assured that the electrodes will be placed in the indexed AHArecommended positions across various body types and ensured preciseplacement and meet diagnostic criteria for resting- and exertion-ECGanalysis.

An Emergency Cardiac and Electrocardiogram (ECG) electrode placementdevice is a worn device that incorporates elastic electrical conductingmaterials and elastic material into a pad that is applied to the chestwall placing the electrodes in the appropriate anatomic locations in arapid, reproducible, reliable fashion. It is provided in a compact,easily stored and transported form that is applied to the chest wallwith materials that have adhesive capabilities that resist moisture andconforms to the body with inherent elasticity with placement ofelectrodes within the pad that maintain proper anatomic ratios andlocations. This device remains adherent to the body for specific lengthsof time, with examples including adherence for potentially a minimum of48 hours, yet is easily removable, while tolerating physiologic changessuch as sweat or fever or medical treatment, such as CPR. The device isclearly marked and designed to fit to the chest wall so that itsapplication ensures proper placement of all electrodes. The incorporatedelectrical conducting materials combine together into a singlecable/wire that is either directly or indirectly joined to an ECGmonitoring device. The cable has adaptor capability that allows forwireless transfer of data to an ECG monitoring device obviating the needfor having a bulky ECG machine in close proximity to the patient. Thesingle cable also eliminates the need for multiple wires on a patient.Multiple wires that could potentially interfere with diagnostic imagingsuch as chest radiographs, or interfere with placement of emergencymedical equipment such as transcutaneous cardiac pacer pads ordefibrillating pad.

One aspect of the present invention is a wearable diagnosticelectrocardiogram (ECG) garment comprising a garment body andscreen-printed electrodes positioned on the body.

The screen-printed electrodes preferably include concentric ringelectrodes, and each of concentric ring electrodes is a bipolarelectrode or a tripolar electrode.

The wearable diagnostic ECG garment also preferably comprisesscreen-printed wires. Each of the screen-printed electrodes connected toa screen-printed wire. The wearable diagnostic electrocardiogram garmentalso preferably comprises a central connector module, wherein each ofthe screen-printed wires is connected to the central connector module.The wearable diagnostic electrocardiogram garment also preferablycomprises a wireless transmitter connected to the central connectormodule. Each of the screen-printed wires and each of the screen-printedelectrodes is preferably composed of a screen printable conductivesilver. The electrodes are preferably ten electrodes indexed to meet AHAguidelines for diagnostic criteria 12-lead ECG and additional nodepositions for diagnostic studies for right sided interpretation andposterior interpretation lead positioning.

Another aspect of the present invention is a wearable diagnostic ECGgarment comprising a garment body, screen-printed electrodes positionedon the body, a central connector module, and screen-printed wires on thegarment body. Each of the printed wires is connected from the centralconnector module to an electrode of the screen-printed electrodes.

Yet another aspect of the present invention is an emergency cardiac andECG electrode placement device. The device comprises a body andscreen-printed electrodes. The body comprise extension members. The bodycomprises a base layer composed of a flexible material, an adhesivelayer composed of a flexible material, and a backing layer attached toan adhesive surface of the adhesive layer. Each of the extension membersextend outward from a center of the body for proper placement of theelectrodes on a patient.

Having briefly described the present invention, the above and furtherobjects, features and advantages thereof will be recognized by thoseskilled in the pertinent art from the following detailed description ofthe invention when taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

FIG. 1 illustrates a shirt embodiment of the emergency cardiac and ECGelectrode device.

FIG. 1A illustrates a shirt embodiment of the emergency cardiac and ECGelectrode device.

FIG. 2 illustrates a shirt embodiment of the emergency cardiac and ECGelectrode device.

FIG. 3 is an illustration of an emergency cardiac and ECG electrodedevice.

FIG. 4 is an isolated view of a portion of an emergency cardiac and ECGelectrode placement device.

FIG. 5 is an illustration of a multi-electrode screen printed design.

FIG. 6 is a screen-printed concentric electrode embodiment with anuniaxial strain silver and ecoflex with a stencil coated on the back ofthe tape.

FIG. 7 is a screen-printed electrode embodiment with serpentine design.

FIG. 8 is an illustration of a multi-electrode screen printed design ina serpentine embodiment.

FIG. 9 is an illustration of screen-printed electrodes V2-V6.

FIG. 10 is an illustration of screen-printed electrodes.

FIG. 11 is an illustration of screen-printed electrodes.

FIG. 12 is an isolated cross-sectional view of an extension andelectrode of an emergency cardiac and ECG electrode placement device.

FIG. 13 is an illustration of a first embodiment of an emergency cardiacand ECG electrode placement device positioned on a patient.

FIG. 14 is an illustration of a second embodiment of an emergencycardiac and ECG electrode placement device positioned on a patient.

FIG. 15 is an illustration of a third embodiment of an emergency cardiacand ECG electrode placement device with a defibrillation mechanismpositioned on a patient.

FIG. 15A is an illustration of a fourth embodiment of an emergencycardiac and ECG electrode placement device with a defibrillationmechanism positioned on a patient.

FIG. 15B is an illustration of a fifth embodiment of an emergencycardiac and ECG electrode placement device with a defibrillationmechanism positioned on a patient.

FIG. 15C is an illustration of a sixth embodiment of an emergencycardiac and ECG electrode placement device with a defibrillationmechanism positioned on a patient.

FIG. 15D is an illustration of a seventh embodiment of an emergencycardiac and ECG electrode placement device positioned on a patient.

FIG. 16 is an isolated bottom plan view of a bottom surface of anextension of an emergency cardiac and ECG electrode placement device.

FIG. 17 is an isolated top plan view of a top surface of an extension ofan emergency cardiac and ECG electrode placement device.

FIG. 18 is a bottom plan view of a multi-electrode screen-printeddesign.

FIG. 18A is a top plan view of a multi-electrode embodiment of FIG. 18.

FIG. 19 is an illustration of a concentric ring electrodes embodiment.

FIG. 19A is an isolated view of a multipolar electrode of FIG. 19.

DETAILED DESCRIPTION OF THE INVENTION

As shown in FIGS. 1, 1A and 2, a wearable diagnostic electrocardiogram(ECG) garment 100 worn by a user 15 comprises a garment body 110,screen-printed electrodes 115, an electrode connector 170, a wirelesstransmitter 175, and screen-printed wires 105. The screen-printedelectrodes 115 V1-V6 are positioned on the body 110. The electrodeconnector 170 preferably extends from the body 110. The screen-printedwires 105 are positioned in the garment body 110. Each of the wires 105is connected from the electrode connector 170 to an electrode 115 V1-V6.

The wearable diagnostic ECG garment 100 preferably also comprises ofexternal electrodes. The garment body 110 of the ECG garment 100 ispreferably a long sleeve shirt, a short sleeve shirt or a robe, and iswashable. The ECG garment 100 further preferably has a cable managementmodule, sensors, and a wireless transmitter 175.

The ECG garment 100 is preferably a 12 lead ECG. The screen-printedelectrodes 115 are preferably comprised of ten electrodes indexed tomeet AHA guidelines for diagnostic criteria 12-lead ECG and additionalnode positions for diagnostic studies for right sided interpretation andposterior interpretation lead positioning. A diagnostic ECG from the ECGgarment 100 conforms to the American Heart Association (AHA) guidelines.

As shown in FIG. 3, an emergency cardiac and ECG electrode device 20preferably comprises a body 21 and screen-printed electrodes 115. Thebody 21 preferably comprises a center extension member 22, a secondextension member 23, a third extension member 24, a fourth extensionmember 25, a fifth extension member 26, a sixth extension member 27, anda seventh extension member 28. Each of the extension members 22-28extend outward from a center of the body for proper placement of theelectrodes 115 on a patient. Each extension member 22-28 preferably hasa width ranging from 1 cm to 10 cm, and a length ranging from 5 cm to 20cm. The body 21 further comprises a base layer 30 composed of a flexiblematerial, an adhesive layer 31 composed of a flexible material, and abacking layer 32 attached to an adhesive surface 31 a of the adhesivelayer 31.

In an alternative embodiment, an emergency cardiac and ECG electrodedevice 20 preferably comprises a body 21, screen-printed electrodes 115,and an electrode connector cable 60 extending from the body 21. The body21 preferably comprises a center extension member 22, a second extensionmember 23, a third extension member 24, a fourth extension member 25, afifth extension member 26, a sixth extension member 27, and a seventhextension member 28. The body 21, as shown in FIG. 12 as across-section, further comprises a main layer 30 having a top surface 30a and an adhesive surface 30 b, and a backing layer 32 attached to anadhesive surface 31 a of the adhesive layer 31. An electrical conductingelastic material is incorporated into the top surface 30 a. Each of thescreen-printed electrodes 115 are positioned on the adhesive surface 30b of the main layer 30. Each screen-printed electrode 115 is furtherconnected to the electrode connector cable 60 through the electricalconducting elastic material of the main layer 30.

One preferred material for the flexible material is KT TAPE fromSpidertech. The top layer 30 preferably has a Shore A hardness rangingfrom 50 to 90, which better allows for chest compressions. One preferredmaterial for the adhesive layer is an adhesive from 3M.

As shown in FIG. 4, a screen-printed wire 60 a connects the electrode 50a to the electrode cable connector 71. A screen-printed wire 60 bconnects the electrode 50 b to the electrode cable connector 71. Ascreen-printed wire 60 c connects the screen-printed electrode 50 c tothe electrode cable connector 71. A screen-printed wire 60 d connectsthe screen-printed electrode 50 d to the electrode cable connector 71. Ascreen-printed wire 60 e connects the screen-printed electrode 50 e tothe electrode cable connector 71. A screen-printed wire 60 f connectsthe screen-printed electrode 50 f to the electrode cable connector 71. Ascreen-printed wire 60 g connects the screen-printed electrode 50 g tothe electrode cable connector 71. A screen-printed wire 60 h connectsthe screen-printed electrode 50 h to the electrode cable connector 71. Ascreen-printed wire 60 i connects the screen-printed electrode 50 i tothe electrode cable connector 71. A printed wire 60 j connects theelectrode 50 j to the electrode cable connector 71. A ten pin electrodeinterface 75 connects to the electrode cable connector 71. On oneembodiment, the elastic electrically conductive material is preferablyapplied with a 3D printer directly on the main layer.

Alternatively, an elastic conductive material is substituted for each ofthe printed wires in FIG. 4. Such elastic conductive materialspreferably comprise silver chloride and/or graphene. The body 21 ispreferably composed of a kinesiology type tape.

In FIG. 5 an illustration of a multi-electrode screen printed design isshown.

FIG. 6 shows a screen printed concentric electrode embodiment with anuniaxial strain silver and ecoflex with a stencil 81 coated on the backof the tape 80. The screen-printed concentric electrodes 115 have afirst section 115 a and 120 b, encompassed by a second section 120 a and125. They are preferably stretchable (30% strain), and adhesive withoutusing conductive gel. The electrodes are fixed on one bandage (to avoiduser confusion on lead placement/connection). The electrical shieldingfor the electrode band preferably shields against high voltage ofdefibrillator (2500-5000 V, typical current ˜20 A, biphasic 200 J over10 ms). The wiring design minimizes signal distortion under mechanicalstrain.

In FIG. 7, the tape has a width of 5 cm (need 5 electrodes for V2-V4 atonce). The sacrificial layer 77 is dissolved to allow serpentines todelaminate from the substrate and to be free to buckle upon stretching.The layers comprise of a serpentine backbone layer 74, insulating layers73, a conductive serpentine layer 76, a sacrificial layer 77, aconductive island layer 78, and an island backbone layer 79.

In FIG. 8, a backbone is coated on the tape first (using Ecoflex). Wireinsulation is preferably of: Dielectric Strength (ASTM D-147-97a): >350volts/mil. A screen-printed serpentine pattern 120 is created to fitV2-V6 and a stencil is made: The Ecoflex backbone is coated directly onthe fabric; measure the maximum resistant and strain; take ECGmeasurements with these electrodes 115.

FIGS. 9-11, show a serpentine design with lowered resistance. Execution:Exoflex backbone allowed to stencil electrode on the sticky side 85 ofbandage; Less ecoflex to silver ratio also reduced the resistance;evaluate the strain & make measurements with the ECG device. Theelectrode 115 surface is coated with hydrogel 116 to reduce interfacialresistance. Rearrange the connections and plan for connection to thelead hub (wires instead of clips). The hydrogel 116 is preferablycomposed of Polyvinyl Alcohol (PVA), Poly(3,4-ethylenedioxythiophene)Polystyrene Sulfonate (PEDOT:PSS) for conductivity.

As shown in FIG. 13, an EXG device 20 preferably comprises a body 21,electrodes 50, printed wires or an electrical conducting flexiblematerial 60 (not shown), and an electrode cable connector 71. The body21 preferably comprises a center extension member 22, a first extensionmember 23, a second extension member 24, a third extension member 25 anda fourth extension member 26. The electrode cable connector 71 ispositioned on the body 21. Each extension member 22-26 preferably has awidth ranging from 1 cm to 10 cm, and a length ranging from 5 cm to 20cm. The center extension member 22 preferably comprises a firstelectrode 50 a, a second electrode 50 b, a third electrode 50 c, afourth electrode 50 d, a fifth electrode 50 e and a sixth electrode 50f. Screen-printed wires or electrical conducting flexible material 60(not shown) connect each electrode 50 to the electrode cable connector71.

Other embodiments of EXG device 20 are shown in FIGS. 14 and 14A. Theextension members extend outward from the center of the body 21.

Alternative embodiments of the EXG device 20 a, shown in FIGS. 15, 15A,15B, and 15C, also comprise integrated defibrillation pads 40 a and 40 bconnected to a defibrillation cable 41. In an unstable patient,defibrillation becomes a crucial aspect of emergency cardiac care. Theuse of defibrillation pads has in the field historically been done withpad placement at the discretion of the first responder/paramedic. Themost common deployment being anteriorly. This often leads to suboptimalplacement and suboptimal delivery of electricity. The EXG-DF withdefibrillator pad assures proper placement of the device in the anteriorposterior configuration, which allows for optimal electrical conductanceto the heart. The vector of electrical conductance is optimally placedin an anterior posterior configuration. There is no device that providesoptimal defibrillator pad placement while integrating twelve lead EKGability with the ability to extend to include posterior and right sidedlead EKG. The ability to obtain instant EKG data after criticaldefibrillation has heretofore been impractical for the pre-hospital careprovider. The EXG-DF addresses this critical issue in cardiac care.

FIG. 16 illustrates an isolated bottom plan view of a bottom surface ofan extension of an EXG device 20. The bottom adhesive surface 30 b ofthe main layer 30 has electrodes 50 positioned thereon.

FIG. 17 illustrates an isolated top plan view of a top surface of anextension of the EXG device 20. The main layer 30 of the extension has atop layer 30 a with integrated printed wires (or elastic electricalconducting material) 60 d, 60 e and 60 f connected to correspondingelectrodes 50 d, 50 e and 50 f that are positioned on an adhesivesurface below. The electrodes 50 d, 50 e and 50 f are not positioned onthe top surface 30 a of the main layer 30.

FIG. 18 illustrates a bottom plan view of a screen-printed electrode 115embodiment with a serpentine design. An adhesive layer 31 is shown witha piece of the backing layer 32 removed. FIG. 18A illustrates a top planview of the embodiment.

FIG. 19 and FIG. 19A illustrate an ECG device 1900 with screen-printedbipolar electrodes 115 embedded into a body 21 at precordial locations.The device 1900 preferably comprises a body 21 and screen-printedbipolar electrodes 115. The body 21 preferably comprises centerextension members 26-27 for V1 and V2, a third extension member 25, afourth extension member 24, a fifth extension member 23, and a sixthextension member 22. Each of the extension members 22-27 extend outwardfrom a center of the body for proper placement of the screen-printedelectrodes 115 on a patient. Screen-printed wires 120 a-120 j connectthe screen-printed electrodes 115 a-115 j to the central connectormodule 170.

Acquisition of electrode signal from skin surface potentials is enhancedwith the use of concentric ring electrodes in multipolar format that isalso redundant with American Heart Association recommendations forelectrode positioning. By utilizing a redundant design of unipolarelectrodes 115 a in AHA positions and then adding concentric ringelectrodes 125, as shown in FIG. 6 and FIG. 19A, to these same positionswe can provide for a LaPlacian electrocardiography; thus allowing fortraditional ECG interpretation and enhancing this data with LaPlacianmeasures that improve the diagnostic performance. These multipolar(bipolar, tripolar, etc) designs enhance the signal quality from thebody surface potentials. The EXG system can utilize concentric ringelectrodes to capture more detailed electrical activity of the heart andthereby obtain data to that can be used for real-time analysis andfurther machine learning/artificial intelligence allowing for predictiveanalytics to be applied for earlier recognition of disease prior tomeeting the ECG criteria of those events.

The ECG device 1900 is preferably provided in a compact, easily storableand transportable form, that is then applied to a patient's chest wallwith materials that have adhesive capabilities that preferably resistmoisture and conforms to the patient's body with inherent elasticitywith placement of electrodes within a pad that maintains proper anatomicratios and locations. The ECG device 1900 preferably remains adherent tothe patient's body through the duration of the acute pre-hospital andtransition through the emergency department and acute hospitalizationcare periods (which is typically three days), but the ECG device 1900remains easily removable, while tolerating physiologic changes such assweat, fever, and medical treatment, such as cardiac pulmonaryresuscitation (“CPR”). The ECG device 1900 is clearly marked anddesigned to fit to the chest wall so that its application ensures properplacement of all electrodes on the patient. The incorporated electricalconducting materials come together into a single cable/wire that iseither directly or indirectly joined to an ECG monitoring device. Thecable has adaptor capability that allows for wireless transfer of datato an ECG monitoring device obviating the need for having a bulky ECGmachine in close proximity to the patient. The single cable alsoeliminates the need for multiple wires on a patient. Multiple wires thatcould potentially interfere with diagnostic imaging such as chestradiographs, or interfere with placement of emergency medical equipmentsuch as transcutaneous cardiac pacer pads or defibrillating pad.

The ECG device 1900 reduces the time to perform ECG testingsignificantly. With proper training, a user can anticipate ECGacquisition in less than one minute, and potentially within seconds.Current ECG data can take several minutes or longer depending on thecare setting. It is not unusual for an ECG ordered in a hospital settingto take more than 10-30 minutes.

The ECG device 1900 also eliminates lead transposition error, which isthe attachment of an electrode wire in a wrong electrode.

The ECG device 1900 makes ECG data more reliable and reproducible. Thereis no variation in lead placement while performing serial ECGs—which isoften done in the hospital and pre-hospital setting. The incorporatedelastic electro-conductive materials allow for this small form factor toaccommodate varying body types (man, women, adult, child, obese,anorexic) while maintaining strict anatomic ratios and correct placementand ensure proper lead placement.

The ease of use of the ECG device 1900 makes ECG acquisition lessinconvenient and potentially improves ECG utilization in thepre-hospital setting.

The ECG device 1900 also reduces the frequency of lead detachment.

An alternative embodiment of the EXG system has wireless transfercapability that makes acquisition of the ECG in any situation feasible.

The ECG device 1900 preferably incorporates either integrated elasticelectro-conductive materials or printable elastic electro-conductivematerial used in the acquisition of electrical signals from theelectrodes.

The ECG device 1900 adheres to skin surfaces through a variety ofphysiologic conditions not currently met by current methods.

The ECG system allows for acquisition of data in settings that standardmethods currently fail.

Existing technology for ECG acquisition relies on technical expertise inlead placement.

Removing technical error is dependent of operator knowledge and skill,as well as interpretation of ECG data to identify systemic error inplacement.

The time to acquire an ECG is dependent on many factors but is limiteddue to the number of electrodes that are placed on the chest and torso,which then need to be attached to the ECG device. There are preferably aminimum of ten wires involved, and more electrodes are possible to allowfor more specific views of the right side of the heart and/or posteriorheart leads.

The ECG device 1900 solves the problem of lead detachment, leadreversal, inability to apply leads due to extremes in physiology, andlack of reproducibility to measure subtle changes. The ease of use withEXG allows for acquisition of ECGs that would not have been obtained andtherefore limits the opportunity loss of delays in diagnosis andtreatment. The use of an elastic pourable or printable or otherwiseapplied film of elastic conductive material will replace bulky standardcables and wires allowing for a more compact form, smaller footprint,and contribute to less material and weight of the device.

In one embodiment, the EXG device preferably comprises: adhesivestretchable material that is breathable and water/sweat resistant;embedded elastic electroconductive material conducting electricalsignals from the integrated cardiac electrodes to a central data cable;embedded elastic electroconductive material/wiring/cabling arranged toallow for stretching across body types and sizes; electrode connectionport; Bluetooth capable emitter and receiver; conduction gel; andembedded electrodes (manufactured or printable).

The elastic adhesive membrane preferably provides adherence to bodysurface. It is preferably tolerant to moisture. The ECG devicepreferably incorporates electroconductive materials and electrodes thatconduct signal from the skin to a single data cable/wire. The ECG devicepreferably expands in an elastic fashion to appropriately fit variedbody types while meeting exact ratios of electrode distance withoutdistortion. The ECG device preferably has significant stability of sizeand shape with elastic components to make it easily applicable to thechest wall. The ECG device preferably comes in a compact form factor.

In one embodiment, there is encapsulated expandable electroconductivematerial within the membrane. Within the elastic membrane isincorporated electroconductive materials that originate from eachelectrode to bring the cardiac electrical signal to the monitoringdevice via a single data cable encompassing all appropriate ECG leads.This will be a novel use of new technology using elasticelectroconductive printable materials that will stretch with theelectrode assembly pad and retain conductivity. Potentially use existingelectroconductive materials to expand and contract with the device todeliver electrode signals to the monitoring equipment.

Alternatively, the ECG device allows for the use of external electrodes.In the event that ECG monitoring equipment is not compatible with thedata cable, electrodes at the ascribed anatomical locations can beaccessed with standard medical cardiac monitoring and ECG devices.

In one embodiment, there is a conductive membrane at ECG electrodesites. At the ascribed electrode ECG locations is a typicalelectroconductive Ag/AgCL membrane to conduct current from body surfaceto ECG monitoring device.

In one embodiment, a data cable brings individual electrodes into onecable that encompasses a minimum of ten wires/leads of the typical ECGanalysis which is then compatible with various ECG devices and wirelesstransfer system. Other conductive interfaces may be utilized with theinvention including ones composed of graphene/carbon, nickel, andcopper.

In use, one applies the ECG device 1900 to an anterior chest walloverlying the sternum symmetrically at a level above the nipple line ofthe patient and below the sternal notch, removing the backing layer 32to expose the adhesive surface 31 a of the adhesive layer 31. Theprecordial limb is then stretched to the lateral chest wall at the midaxillary line below the nipple line. Similarly each limb will have thebacking layer 32 removed in succession to expose the adhesive surface 31a of the adhesive layer 31. The right upper extremity limb is stretchedtowards the right shoulder. The left upper extremity is stretchedtowards the left shoulder. The right lower extremity limb is stretchedto the right lower abdominal quadrant. The left lower extremity limb isstretched to the left lower abdominal quadrant. The cable is eitherattached to directly to the ECG device cable. Or in versions utilizing aBLUETOOTH transceiver, then the ECG device 1900 is activated to syncwith the BLUETOOTH transceiver that is already connected to the ECGdevice.

Another embodiment has a posterior extension member which preferably hasmultiple electrodes that connect via a cable to an intermediary adaptermodule which connects to the electrode cable connector. The posteriorleads preferably are connected through the adapter module onto the endof the original ECG device 1900 and basically take over leads V5-6 forthe standard ECG.

In an alternative embodiment, the ECG device 1900 comprises a wirelessemitter and a wireless receiver. The wireless emitter is connected toelectrode cable connector, and the wireless receiver is connected to anECG machine. The wireless emitter and the wireless receiver preferablyoperation on a BLUETOOTH communication protocol. However, those skilledin the pertinent art will recognize that other wireless communicationprotocols may be utilized with the alternative embodiment of the ECGdevice 1900 without departing from the scope and spirit of the presentinvention.

In another embodiment, the ECG device 1900 also preferably comprises aplurality of external electrodes.

The stretching capability of the extension members of the ECG device1900 preferably extends from a length L1 ranging from 7.0 to 14.0 inchesto a length L2 ranging from 10.0 to 16.5 inches. In a most preferredembodiment, L1 ranges from 10 to 11 inches, and L2 ranges from 12 to 13inches. A width of each extension member 22, 23, 24, 25, 26 preferablyranges from 1 centimeter (“cm”) to 10 cm, and most preferably 2.5 cm to5 cm. A thickness of each extension member 22, 23, 24, 25, 26 preferablyranges from 0.1 inch to 0.5 inch.

The emergency cardiac and ECG electrode placement device 1900 is capableof being applied to a patient while an emergency vehicle is in motionsince the device 20 is applied to and adheres to a patient's chest area,which mitigates signal loss. Likewise, the emergency cardiac and ECGelectrode placement device 1900 is capable of being applied to a patientthat is moving due to a seizure, aggressiveness, and the like.

A preferred source for the printed wires is PE874 conductor ink fromIntexar Dupont. Those skilled in the pertinent art will recognize thatother printed electrically conductive materials may be used withoutdeparting from the scope and spirit of the present invention.

The ECG device 1900 is a stretchable adhesive fabric utilizing amultitude of electrodes and wires to allow for adjustable sizing withina single device across most adult requirements. This device allows forboth non-adhesive and adhesive electrodes to be placed via a re-useablefabric garment that has indexed positioning and capability of beingwashed for re-use. The garment further allows the attachment ofadditional physiology monitors such as blood pressure assessment andnon-invasive assessment of tissue and capillary oxygenation as well asrespiratory variation and pulse oximetry. Often, patients aretransported between locations and require bulky monitors to travel withthem, whereas this smart-garment allows for compact, within garment,transmission and limits the need for multiple ancillary physicalmonitors. It also allows for this data to be obtained reliably at homeand is pertinent to those patients who would benefit from continued athome telemetry. The device is compatible across a plethora of existinghardware and manufacturers and can be encased in water-proof material toallow for monitoring in austere environments. The device can be sizedfor infants as well as children and adults. The use of non-adhesiveelectrodes allows for multiple re-use with greater comfort and improvedcompliance.

The specific problem resolved by the present invention is that reliableacquisition of a diagnostic 12 lead ECG within and outside of thetraditional health care setting by medically-trained persons as well aslaypeople with little training is difficult. The lead positions and theinability to obtain a 12 lead ECG without investing in costly equipmentand training make this important medical knowledge inaccessible to mostpersons unless they are in a traditional health care setting.

The present invention preferably utilizes adhesive and non-adhesivestandard ECG electrodes; shielded and insulated wires for dataacquisition and transfer; and stretchable garments made from combinedmaterials such as polyester, spandex, gortex and cotton withstrategically placed eyelets that allow for device attachment atspecified positions for accurate physiologic monitoring.

The ECG garments 100 are stretchable elastic fabric types that can belong or short sleeved with extensions down to the proximal limb regions.

The ECG garment 100 comprises 10 electrode placement nodes, indexed tomeet AHA guidelines for diagnostic criteria 12-lead ECG, and additionalnode positions for diagnostic studies for right sided interpretation andposterior interpretation lead positioning.

The ECG garment 100 comprises conductive materials to transmitelectrical signals from the electrodes to a central unit. The centralunit receives all electrical signals and can be integrated with wiredtechnology to standard ECG machines for interpretation. The central unitreceives all electrical signals from the electrodes and can beintegrated with a wireless transmitter for reception by a device such asa cell phone, an ECG machine, or a cloud based system for ECGinterpretation.

The method steps of the invention begin with applying pre-wired garment100 to anterior chest resting the center chest piece at the markedindication for the nipple line. This assures indexed positioning of thedevice and alignment with the precordial positions. Next, stretch thegarment so it rests at least to the level just distal to the hip jointat the lower limbs and distal to the shoulder joint at the proximallimbs. Stretching the garment to the proximal limb positions havingprior adequate precordial positions now satisfies the AHA guidelines fordiagnostic resting ECG interpretation. Next, the left sided electrodeshould rest at the mid axillary line and below the nipple level whenlying down. This ensures adequate lateral positioning of the device. Thedevice can be further secured for external activity by looping aconnection around the torso, neck and proximal limbs. Securing thedevice to the torso and limbs allows for continued monitoring duringmovement and/or exertion and limits the single noise induced withshifting lead positions. A modified version is incorporated into a longshirt like garment. A mother modified version includes an innerstretchable fabrics layer as described above that is conformable whilean outer loose layer of cotton forms a gown typical of hospital use withclosures at the neck and sides or directly with a multitude ofenclosures such as tooth-in-groove binding or stud-eyelet-grooveattachments.

The electrodes include a multitude of designed electrodes to improvesignal to noise ratio through use of designs which limit wire movementand improved signal processing from skin electrodes which are designedwith bipolar and tripolar concentric ring electrodes. These electrodesare flexible and elastic with improved spatial resolution. They areprintable by methods of screen printing and methods of 3D printingdirectly to fabric. The design of the interface between the electrodeand the lead is optioned to allow for exchange/replacement of electrodeswhich offers re-useablity. The flexible electronic composition allowsfor conformity to various body habitus while preserving the integrity ofsignal quality at rest and in motion.

The skin-to-electrode interface preferably is comprised of either AgClprinted gel, graphene, or copper with overlying AgCl.

In one embodiment, metallic electrodes are specifically designed to becovered with re-placeable AgCl covers. This allows for insertion intospaces within the fabric for improved positioning, hold, andremovability which allows re-use.

In one embodiment, a printable electrode design demonstrates aninterface between the leads and the electronic components for taking theanalog data and passing through either an analog connector directly to abedside traditional ECG instrument or the option of wirelesstransmission with an analog-to-digital transmitter with a reciprocatingreceiver for connectivity to instruments or cloud-based ECG analysis.

In one embodiment is a modular design of printable electrodes and fabriclimbs with a central chest piece for index anatomical positioning andcentral attachment of leads for signal transmission/connection. Thismodular design allows for ECG analysis with traditional 12-lead, 15Lead, Right-sided lead positions, and posterior lead positions whichencompasses the totality of acute diagnostic lead positioning in acutecare.

The ECG garment as a robe/gown will have Velcro-like pulleys forcompression positioning of the electrodes against the proximal limbs andacross the chest and will afford various height adjustments andadjustments for girth.

The ability to take population data to a granular individualized levelof risk is the specific problem the ECG platform solves. Aggregate datafrom populations does not translate well to individual risk and thislack of specificity leads to an abundance of treatment applied toindividuals that may not be of benefit and additionally adds costs thatinduce burden to the overall health system. Furthermore, the eXgplatform will allow for AI interpretations that exceed currentlimitations of poor physiologic variability in exercise testingutilizing computer-interpreted ECG or segment analyses.

In another embodiment, the invention provides a data collection andrepository of diagnostic-level information that is reliable and accuratefor frequent re-sampling and simulation of algorithms to be applied topredict the likelihood of cardiac-related events. The thresholddetermination of those events defined by goodness-of-fit and explanationof variance from individualized baselines will afford the opportunity toidentify an adaptive solution that improves the population-levelstatistic to an individual level risk of event. For instance, anindividual through frequent re-sampling could undergo statisticalanalysis via Monte-Carlo simulation fortified by confidence fromresampling to serve as both collection/investigation- and validation-setof data to predict their individualized outcome of wave morphology. Thistype of analysis is not afforded by the current art nor performed bycurrent computer-interpreted ECG analysis. Even in standardized cardiacexercise testing there are significant limitations to ECG-segmentanalysis in settings of heart block or prior injurious patterns. The EXGplatform can allow for improved recognition of events in these subsetsnot currently covered by the existing art.

Using the ECG garment 100 will reduce the time to complete anelectrocardiogram (ECG) in the pre-hospital and emergency setting,eliminate systematic error in placement and interpretation of an ECGelectrode, maintain and place electrodes in the proper anatomiclocations across all body types, will not delay management in criticalcase, maintain proper skin contact through different physiologicresponses such as sweat, cold and heat, as well as through medicaltreatment such as CPR, be easy to train providers in application andplacement of ECG electrodes, and be adaptable to scenarios where spaceand situations limit ECG placement.

The ECG electrocardiogram system acquires cardiac electrical data onsubjects. This system is in accordance with American Heart Associationdiagnostic quality electrode placement. The acquisition of this realtime data from subjects over the course of days and months has thepotential to add to our knowledge of cardiac electrical activity and itsassociation with various physiologic conditions. Classically, theelectrocardiogram (ECG or ECG) has been used to diagnose a multitude ofcardiac abnormalities. Examples of such include but are not limited to:myocardial infarction (heart attack), rhythm abnormalities (eg atrialfibrillation, supraventricular tachycardia, ventricular fibrillation andmany others), electrolyte disorders (potassium, calcium and others),environmental exposures, physiologic stressors such as infection,cardiac output, and toxic exposures to name a few. With the acquisitionof quality electrocardiogram data with the eXg system there is potentialfor further development of Artificial Intelligence (AI) algorithms andanalytics heretofore unexplored.

With EDAPT and the development of a database of qualityelectrocardiograms coupled with matched subject health informatics, theability to develop an AI engine that will be predictive of cardiacevents with potential to mitigate morbidity and mortality isanticipated. Current ECG algorithms focus on static data analysis withinterpretation of ECG data based on standard concepts ofelectrophysiology. Development of a database of ECG information coupledto AI will move forward from interpretation of data to prediction ofoutcomes. EDAPT is that system.

Heretofore electrocardiogram monitoring has been studied with amultitude of leads for rhythm analysis but the diagnostic gold standardis the 12 lead ECG. In practice when an abnormal rhythm is detected thisis to be followed by a 12 lead study for diagnostic purposes. Thelimitation of applying this monitoring across healthcare settings is theability to have a skilled interpretation of abnormalities that areclinically relevant. The pre-existence of persistent electrical axisshift or abnormal wave morphology such as that which occurs in leftbundle branch, as a single example, illustrates the added difficulty indiagnosing acute myocardial ischemia. The EXG platform would allow for astable baseline to be ascertained from which the subtle changes ofSgarbossa criteria could be applied to recognize the onset of acutemyocardial infarction through machine and deep learning methodology.More importantly the data repository that the EXG platform providescould allow for predictive analytics to be applied in real-time toforecast that someone was soon to meet the Sgarbossa criteria andthereby save time in recognizing an impending myocardial infarctionwhich could significantly reduce the infarction time and allow forinterventions that would have a downstream effect of limiting the morbidsequelae of these events with preserved cardiac output. These type ofresults would limit the rehabilitative requirements for patients andwould allow for a quicker return to normal activities, thereby resultingin a significant improvement in quality of life adjusted metrics. Theability to use this data repository through real-time predictiveanalytics on an individualized level of care would provide granulardecision making that is not otherwise possible without AI on apopulation level. There is a question in medical education a resident isasked, when tasked with interpreting an abnormal ECG, “what is worth athousand cardiologists?”. The answer: An old ECG. The prior recorded ECGallows for the determination of a complex abnormal current ECG to beplaced into context of which waves are new or dynamic and is better thanthe most learned opinion of a single ECG which is why the baselineassessment is so valuable.

The ECG platform is a data collection repository from which continuousphysiologic and diagnostic-level information can be re-sampled atfrequencies not obtainable by current methods. The frequency ofre-sampling allows for simultaneous establishment of baseline definitionas well as recognizing departures from that baseline. The underlyingprocess is recognition of standardized definitions of acute criteriasuggestive of a cardiac abnormality, for example, myocardial infarction,which is similar to current algorithmic software embedded in most ECGmachines. The difference in the ECG platform is that there is ananalysis of beat to beat variability and prolonged sampling andresampling to recognize the evolution of a cardiac event and thenapplied machine and deep learning to produce a predictive framework fromwhich a clinical pathway can be produced to optimize care. Mostimportantly this data repository can allow for an exploration ofclinical pathways not currently considered. For instance, patients withsyncope who have abnormal ECGs are deemed at risk of a major cardiacevent and admitted to hospital. Through the EXG platform we may be ableto recognize not only which patients should be admitted or dischargedbut also have improved prediction of which patients requireinterventions such as pacemaker insertion. In addition the ECG platformcould allow for estimations of cardiac output and current stroke volumesto estimate intravascular volume status and thereby predict need forintravenous fluid or transfusion requirements. The latter informationhas important implications in triaging patients to appropriate levelfacilities with capabilities to provide level of care appropriate tothat patient at that time.

The use of diagnostic-quality analysis can also provide home users withthe confidence of when it is reasonable to stay home and not pursuecostly healthcare engagement. The recognition of normal, and itsstability, is a key feature to determining if a patient requiresreferral. The ECG platform allows for optimizing performance andtraining. Through continuous monitoring during activity a prediction offluid needs and periods of rest could optimize cardiac output underconditions of exercise and improve exercise tolerance and endurance.Optimizing cardiac health through analysis not currently restricted todiagnosing abnormal health but instead focused on improved health couldhave important implications of reducing needs for healthcare access. TheECG diagnostic level platform will allow the data to be explored todiscover methods to improve cardiac health.

Using the ECG device to capture data from subjects that is thentransmitted to local, networked and cloud based machines.

Continuous 12 lead electrode data acquisition on an individual basis isrecorded and then compared within and between subjects for machine anddeep learning method application. The repository allows for a multitudeof mathematical investigations to produce complex predictive algorithmswhere goodness-of-fit can be applied to improve the explanation ofvariance within and between subjects. The adaptive learning providesexpert level of interpretation on a multitude of patients undergoingsimultaneous monitoring. The broadcast of this information across cloudbased machines and notification to the individual subject withappropriate information and suggestions or reassurances.

The electrodes are placed in prescribed diagnostic positions via aplatform of indexed positioned garments/instruments that conform toAmerican Heart Association and other professional expert guidelines forboth resting-ECG and active ECG interpretation.

Dynamic and changing ECG morphology and data are not currently evaluatedwith current systems. The ability to collect and record and analyzequality ECG data over long periods of subject observation has not beenheretofore easible. The ECG device 1900 coupled EDAPT system will be thebackbone of future AI analytics that will have the ability to predictcertain cardiac events. The EDAPT system will detect physiologic changesthat clinicians in normal practicing scenarios would never be able toreplicate. ECG and cardiac electrophysiologic data is specifically idealfor the use of AI analytics. This is not only applied to recognition ofdisease but also prediction of improved performance and health.

EDAPT with the eXg system will potentially be able to predict cardiacevents based on AI technology and data analysis.

Components for the invention include the following. Standardizedphysiologic electrodes (carbon-based, Silver-based, gold-based,Nickel-based or steel-based). Standardized wires with surroundinginsulation and shielding which reduces nearby electrical interferenceand provides adequate protection. Adhesives or ergonomic garments thatensure reliable application of the electrodes to the skin surface. Wiredconnection between the electrode/wire coupling and an interpretivedevice (ECG machine). Standardized wireless transmitters and receiversthat allow for analog to digital and digital to analog conversions to beused with ECG machines or cloud based machine analysis. ArtificialIntelligence engines that provides machine and deep learning methodologyto apply a multitude of ECG analysis repeatedly to individuals andgroups. Computer data centers as repositories for data collected fromECG devices. Applications on internet connected smart phones that linkto blue tooth and other wireless transmitters to integrate signal anddata processing to the computer and cloud based data centers.

An electrode allows for the acquisition of superficial electricalactivity.

A wireless electrode interface carries the electrical activity to atransmitter or device directly.

A powered transmitter is a long-life Battery Powered Wirelessanalog-to-analog or analog-to-digital transmission with or withoutamplification, or alternatively a direct powered connection betweentransmitter and receiver with or without amplification through a directmachine connection.

A powered receiver is a long-life Battery Powered Wirelessanalog-to-analog or digital-analog receiver with or withoutamplification.

A direct wired connector is a wire to ECG machine interface, multi-pinconnector with or without amplification.

An ECG analytic device is a Cloud based or direct machine basedinstrument to interpret and allow display of the above data foranalysis.

Artificial Intelligence is a complex mathematical analysis based onrepeated sampling of the continuous ECG data and defined by standardsegments of sampling (eg. 2.5 sec) then re-sampled at a multitude offrequency to allow for predictive analytics.

A stretchable garment with adaptive interface for varied electrodepositioning is a stretchable and durable fabric to allow for adequateapposition of

electrode to skin with appropriate integrity and indexed positioning.Also afford an interface for the wires and electrode to allow removaland reuse which affords appropriate hygiene and durability of themodular components.

Indexed center chest piece for wire management is the center chest pieceallows for variable wire length and positioning to afford individualizedelectrode placement with a standard set of wire lengths. The chest pieceis indexed to the center of the chest and the resting nipple line.Correct anatomical indexing assures the diagnostic positioning of theelectrodes.

A data repository is an anonymized data set of continuously broadcastphysiologic measurements on a subject level basis. The aggregate ofsubject data allows for population analysis as well. The data set iscomprised of 12 lead analog and digital signals corresponding to theelectrode positions obtained over the duration of product use. Dataexists in a format commensurate with current standards for wireless data(mp3, mp4, etc.).

An alarm and light indicator is an alarm and light indicators on thedevice to notify a patient of a visual and auditory cue that there is arequired response to the data analysis/prediction.

In a method of practicing the invention, the first step is a patientapplies the ECG garment 100. Indexed positioning of the electrodes toposition along the proximal limbs below the shoulder joint and hip jointand along the precordium as described by AHA standards for diagnosticresting ECG analysis. Next, the patient or technician connects thepowered transmitter for transmission of the electrode data to areceiver. Next, the patient or technician connects the powered receiverwhich is individual coupling a specific transmitter to a specificreceiver maintain fidelity of data receiver may be attached to aECG-device directly or to a data transmission device like a smartphoneto a cloud-based ECG analysis. Next is ECG interpretation which is 2.5sec continuous and either 3, 6 or 12 channel simultaneous and/orimmediate consecutive analysis of a multitude of wave-morphology,wave-segments, and wave intervals analysis based on published diagnosticstandards. Next, is the AI interface which is repeated sampling andwithin individual and population level repetitive analysis of ECGinterpretation with machine and deep learning methods of predictions ofimpending changes of wave morphology, wave segments, or wave intervalsand amplitudes. Additional analysis of variance coupled with timedserial comparisons. Next is data repository which is the collection ofECG-individualized data from which we can further analyze potentialclinical pathways and predictions of cardiac health and stability and/orinstability.

The input of a transcutaneous electrical activity acquired fromstandardized electrode interface gives an output of an electricalactivity transferred along the ECG system representing a reliable analogmeasurement of the transcutaneous-derived signal.

The input of an ECG device interface with ECG analytic device/cloudbased analysis gives an output of an analog data transmitted to ECGinterpretive device for diagnostic assessment of specific electricalaxis of wave amplitudes, morphology and segments and intervals.

The input of Artificial Intelligence Software, resampling of definedduration and repeated assessment frequency gives an output multitude ofreassessments across multiple patients simultaneously with predictiveanalytics and machine and deep learning application of risk predictionof significant and clinically relevant changes in wave amplitudes,morphologies, and intervals.

The input of a data repository gives an output of a large dataset ofindividual AI analyses summed into population level analytics to predicthealth outcomes on a population level and allowed refinement andinvestigation of individual level analytics. Temporary localrepositories could be coupled with a smart-device that could laterupload the data to the larger repository.

With current technology utilizing the ECG-system and artificialintelligence (AI) algorithms, the potential to expand the emergencydepartment safely to include the waiting room is now feasible. Thepotential to monitor all patients with chest pain remotely and safelywith diagnostic AI systems will decrease missed diagnosis, increaseaccuracy, and improve safety throughout the healthcare system. The ECGsystem coupled with a continuous 12 lead central monitoring system usingpatented artificial intelligence to detect subtle changes in the ECGregardless of patient location is now a reality. With application of aportable reliable and diagnostic ECG monitoring device, the ECG willinterface wirelessly with a central processing unit capable of detectingsubtle EKG changes dynamically and alert providers of these changes. Itis a perfect blend of AI and healthcare aimed at saving lives.

Current systems evaluate patients with acute coronary syndrome withpoint estimate EKG and serial serum enzyme testing. Recurrent episodesof chest pain and heart attack are often missed due to delays in EKGacquisition and identification for subtle changes in the EKG. Thesepoint estimates have been the only feasible option for healthcareproviders, until now. Patients at high risk for disease especially inthe era of emergency department overcrowding and delays and triage andpatient assessment raise the risk for morbidity and mortality. Serialassessments of ST segment and other subtle changes indicative of acutecoronary syndrome are time consuming, resource consuming and notfeasible with the current systems. The EXG-system, with its reliableplacement, reproducible data acquisition, ease of use, mitigated motionartifact, allows diagnostic AI to monitor for subtle changes indicativeof cardiac pathology continuously. The EXG-system coupled withcontinuous 12 lead EKG monitoring and wireless connectivity and AIprocessing will better identify patients with acute coronary syndrome,minimize risk of missed MI, and contribute to better patient outcomes.

The ability of AI to perform near continuous evaluation of multiple EKGson multiple patients simultaneously is something that would be anunconventional and non-routine practice scope of any clinician. Onepatient could receive continuous EKGs on the order of up to 20 or moreEKGs per minute. The AI engine would be able to continuously monitormultiple patients at a time with multiple EKGs done during themonitoring period, and that would not be feasible for any clinician.Imagine 20 patients undergoing 20 EKGs per minute over the course of a20-48 hour hospital stay. Thousands of data points being continuouslymonitored and evaluated with diagnostic precision. This novel systemapproach to evaluating patients with presentations concerning for acutecoronary syndrome will potentially decrease frequency of actual EKGacquisition as the AI will identify when changes occur, thus promptingrepeat EKG evaluation versus predetermined arbitrary point estimate EKGacquisition. Potentially obviating need for repeat EKGs if no changesare noted. This will lead to saving lives, saving time and givingclinicians increased confidence in evaluating these patients, regardlessof patient location.

The AI engine will receive data from a continuous signal via wireless orwired technology via the EXG device or any 12 lead continuous monitoringdevice attached to patient(s) to get a first EKG, second EKG, andsubsequent serial EKGs over set intervals that will do standard EKGinterpretation but also compare second EKG and subsequent serial EKGs tothe first EKG and/or baseline EKG and interpret changes. The AI enginewill then be able to determine any significant changes concerning foracute coronary syndrome, arrhythmia, or other diagnostic criteria fordynamic EKG changes in the setting of acute coronary syndrome. Oncechanges or significant findings are made, algorithms will be in place toalert providers of these findings in real time. Data will be stored.Stored data will be available for review and integration into patientcharts and records.

In summary, the EXG device will now allow diagnostic continuous 12 leadEKG monitoring easily, quickly, reliably and safely. Incorporation ofthe device with an AI system will decrease the risk of missed MI in thewaiting room, on the patient floor, and in the emergency department.Similar benefits of an EXG-AI combination could be seen for patients whopresent with syncope (sudden loss of consciousness) where the event maybe related to intermittent arrhythmias that cause an unstable functionof the heart and require pacemaker insertion. This EXG-AI combinationessentially turns every space into a cardiac monitored space thusimproving the resources for an entire hospital where patients now maywait specifically to be placed in a ward with cardiac monitors as themajority of non-ICU hospital rooms do not have cardiac monitorsinstalled.

A conductive elastic rubber material is disclosed in U.S. Pat. No.8,491,884, which pertinent parts are hereby incorporated by reference.

A stretchable graphene film material is disclosed in Chen et al., U.S.Patent Publication No. 20150273737, which pertinent parts are herebyincorporated by reference.

A flexible conductive material comprising silver is disclosed in Taguchiet al., U.S. Patent Publication No. 20130056249, which pertinent partsare hereby incorporated by reference.

Dunphy et al., U.S. Pat. No. 9,986,929 for an Emergency Cardiac AndElectrocardiogram Electrode Placement System is hereby incorporated byreference in its entirety.

Dunphy et al., U.S. Pat. No. 10,893,818 for an Emergency Cardiac AndElectrocardiogram Electrode Placement System is hereby incorporated byreference in its entirety.

Dunphy et al., U.S. Pat. No. D872279 for an Emergency Cardiac AndElectrocardiogram Electrode Placement System is hereby incorporated byreference in its entirety.

Ronan et al., U.S. Pat. No. D877912, for a Cable Controller For AnElectrocardiogram Electrode Placement System is hereby incorporated byreference in its entirety.

McClung et al., U.S. patent application Ser. No. 16/428,927, filed onMay 31, 2019, for an Emergency Cardiac And Electrocardiogram ElectrodePlacement System With Artificial Intelligence is hereby incorporated byreference in its entirety.

McClung et al., U.S. patent application Ser. No. 16/428,984, filed onJun. 1, 2019, for an Emergency Cardiac And Electrocardiogram ElectrodePlacement System With Wireless Electrodes is hereby incorporated byreference in its entirety.

McClung et al., U.S. patent application Ser. No. 16/812,330, filed onMar. 8, 2020, for a Wearable Diagnostic Electrocardiogram Garment ishereby incorporated by reference in its entirety.

From the foregoing it is believed that those skilled in the pertinentart will recognize the meritorious advancement of this invention andwill readily understand that while the present invention has beendescribed in association with a preferred embodiment thereof, and otherembodiments illustrated in the accompanying drawings, numerous changesmodification and substitutions of equivalents may be made thereinwithout departing from the spirit and scope of this invention which isintended to be unlimited by the foregoing except as may appear in thefollowing appended claim. Therefore, the embodiments of the invention inwhich an exclusive property or privilege is claimed are defined in thefollowing appended claims.

We claim as our invention the following:
 1. A wearable diagnosticelectrocardiogram (ECG) garment comprising: a garment body; a pluralityof screen-printed electrodes positioned on the body.
 2. The wearablediagnostic electrocardiogram garment according to claim 1 wherein theplurality of screen-printed electrodes comprises a plurality ofconcentric ring electrodes.
 3. The wearable diagnostic electrocardiogramgarment according to claim 2 further comprising a plurality ofscreen-printed wires, each of the plurality of screen-printed electrodesconnected to a screen-printed wire of the plurality of screen-printedwires.
 4. The wearable diagnostic electrocardiogram garment according toclaim 1 wherein each of plurality of concentric ring electrodes is abipolar electrode or a tripolar electrode.
 5. The wearable diagnosticelectrocardiogram garment according to claim 3 further comprising acentral connector module, wherein each of the plurality ofscreen-printed wires is connected to the central connector module. 6.The wearable diagnostic electrocardiogram garment according to claim 5further comprising a wireless transmitter connected to the centralconnector module.
 7. The wearable diagnostic electrocardiogram garmentaccording to claim 1 wherein the wearable diagnostic electrocardiogramgarment is a 12 lead ECG.
 8. The wearable diagnostic electrocardiogramgarment according to claim 1 wherein each of the plurality ofscreen-printed wires and each of the screen-printed electrodes iscomposed of a screen printable conductive silver.
 9. The wearablediagnostic electrocardiogram garment according to claim 1 wherein theplurality of electrodes is ten electrodes indexed to meet AHA guidelinesfor diagnostic criteria 12-lead ECG and additional node positions fordiagnostic studies for right sided interpretation and posteriorinterpretation lead positioning.
 10. A wearable diagnosticelectrocardiogram (ECG) garment comprising: a garment body; a pluralityof screen-printed electrodes positioned on the body; a central connectormodule; a plurality of screen-printed wires on the garment body, each ofthe plurality of printed wires connected from the central connectormodule to an electrode of the plurality of screen-printed electrodes.11. The wearable diagnostic electrocardiogram garment according to claim10 wherein each of the plurality of screen-printed wires and each of thescreen-printed electrodes is composed of a screen printable conductivesilver.
 12. The wearable diagnostic electrocardiogram garment accordingto claim 10 further comprising a wireless transmitter connected to thecentral connector module.
 13. The wearable diagnostic electrocardiogramgarment according to claim 10 wherein the plurality of screen-printedelectrodes comprises a plurality of concentric ring electrodes.
 14. Thewearable diagnostic electrocardiogram garment according to claim 13wherein each of plurality of concentric ring electrodes is a bipolarelectrode or a tripolar electrode.
 15. An emergency cardiac andelectrocardiogram (ECG) electrode placement device, the devicecomprising: a body comprising a plurality of extension members, whereinthe body comprises a base layer composed of a flexible material, anadhesive layer composed of a flexible material, and a backing layerattached to an adhesive surface of the adhesive layer; and a pluralityof screen-printed electrodes; wherein each of the plurality of extensionmembers extend outward from a center of the body for proper placement ofthe plurality of electrodes on a patient.
 16. The emergency cardiac andECG electrode placement device according to claim 15 further comprisinga plurality of screen-printed wires, each of the plurality ofscreen-printed electrodes connected to a screen-printed wire of theplurality of screen-printed wires.
 17. The emergency cardiac and ECGelectrode placement device according to claim 15 further comprising acentral connector module, wherein each of the plurality ofscreen-printed wires is connected to the central connector module. 18.The emergency cardiac and ECG electrode placement device according toclaim 17 further comprising a wireless transmitter connected to thecentral connector module.
 19. The emergency cardiac and ECG electrodeplacement device according to claim 15 wherein each of the plurality ofscreen-printed wires and each of the screen-printed electrodes iscomposed of a screen printable conductive silver.
 20. The emergencycardiac and ECG electrode placement device according to claim 15 whereinthe plurality of screen-printed electrodes comprises a plurality ofconcentric ring electrodes.